
Ambu A/S
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MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE is an FDA 510(k)-cleared medical device (K071186) manufactured by Ambu A/S. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2007. Regulation: 8.